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Crime in the Pharma Suites

June 2010

Sidney M. Wolfe, M.D.

It never ends. Not a month seems to go by without another major drug company agreeing to pay tens, if not hundreds, of millions of dollars (some more than $1 billion) to the Justice Department to “resolve criminal and civil claims” concerning its illegal behavior.

Unlike pure economic fraud, in which people lose money because of company shenanigans, in these cases people are risking (and possibly losing) their lives and health because of illegal promotion of drugs for which there is no evidence that the benefits outweigh the risks. This so-called off-label promotion, meaning the promotion of a drug approved for treating a certain medical problem for a different disease for which it has never been approved, makes up a significant proportion of the recent crescendo of government cases against the drug industry.

The most recent case involved the company that made Band-Aid, their brand name for bandages, a household term: Johnson and Johnson. This time they were caught and will pay more than $81 million to resolve civil and criminal claims about their illegal, off-label promotion of the drug topiramate (Topamax), approved for treating seizures but promoted for various unapproved uses.

Whistleblower Dr. Gary Spivack, who initiated the case against Johnson and Johnson, said: “I found it outrageous that Ortho-McNeil [a Johnson and Johnson subsidiary] would try to pay doctors to influence them to prescribe a drug for uses that clearly endangered patients’ health. Doctors need impartial and accurate information to make decisions on the best treatment for their patients, but that’s not what Ortho-McNeil provided.” Dr. Spivack alleged in his lawsuit that Ortho-McNeil paid doctors kickbacks to encourage them to prescribe Topamax for a wide range of off-label uses - such as for weight loss, alcohol dependence, eating disorders, and mood and anxiety disorders - despite serious risks to patients’ health.

This is not the first time Johnson and Johnson has been caught illegally marketing drugs. The same is true for most other large pharmaceutical companies. Unfortunately, this lawlessness will not stop until the government penalizes the companies with amounts that are equal or near-equal to the ill-begotten gains they have derived from the illegal activity, not just small fractions. It also must be stated that in none of these cases involving large pharmaceutical companies have any corporate officials been jailed.